Universität zu Köln

Baekgaard, Josefine, Arleth, Tobias ORCID: 0000-0002-7484-6207, Siersma, Volkert, Hinkelbein, Jochen, Yuecetepe, Sirin, Klimek, Markus ORCID: 0000-0002-0122-9929, van Vledder, Mark G., Van Lieshout, Esther M. M., Mikkelsen, Soren ORCID: 0000-0002-5187-7027, Zwisler, Stine Thorhauge, Andersen, Mikkel, Fenger-Eriksen, Christian ORCID: 0000-0003-0536-560X, Isbye, Dan L., Rasmussen, Lars S. and Steinmetz, Jacob ORCID: 0000-0001-9620-8911 (2022). Comparing restrictive versus liberal oxygen strategies for trauma patients - the TRAUMOX2 trial: protocol for a randomised clinical trial. BMJ Open, 12 (11). LONDON: BMJ PUBLISHING GROUP. ISSN 2044-6055

Full text not available from this repository.

Abstract

Introduction Supplemental oxygen is commonly used in trauma patients, although it may lead to hyperoxaemia that has been associated with pulmonary complications and increased mortality. The primary objective of this trial, TRAUMOX2, is to compare a restrictive versus liberal oxygen strategy the first 8 hours following trauma. Methods and analysis TRAUMOX2 is an investigator-initiated, international, parallel-grouped, superiority, outcome assessor-blinded and analyst-blinded, randomised, controlled, clinical trial.Adult patients with suspected major trauma are randomised to eight hours of a restrictive or liberal oxygen strategy. The restrictive group receives the lowest dosage of oxygen (>= 21%) that ensures an SpO(2) of 94%. The liberal group receives 12-15 L O-2/min or FiO(2)=0.6-1.0.The primary outcome is a composite of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome).With 710 participants in each arm, we will be able to detect a 33% risk reduction with a restrictive oxygen strategy if the incidence of our primary outcome is 15% in the liberal group. Ethics and dissemination TRAUMOX2 is carried out in accordance with the Helsinki II Declaration. It has been approved by the Danish Committee on Health Research Ethics for the Capital Region (H-21018062) and The Danish Medicines Agency, as well as the Dutch Medical Research Ethics Committee Erasmus MS (NL79921.078.21 and MEC-2021-0932). A website () is available for updates and study results will be published in an international peer-reviewed scientific journal.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Baekgaard, Josefine UNSPECIFIED UNSPECIFIED UNSPECIFIED Arleth, Tobias UNSPECIFIED orcid.org/0000-0002-7484-6207 UNSPECIFIED Siersma, Volkert UNSPECIFIED UNSPECIFIED UNSPECIFIED Hinkelbein, Jochen UNSPECIFIED UNSPECIFIED UNSPECIFIED Yuecetepe, Sirin UNSPECIFIED UNSPECIFIED UNSPECIFIED Klimek, Markus UNSPECIFIED orcid.org/0000-0002-0122-9929 UNSPECIFIED van Vledder, Mark G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Lieshout, Esther M. M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mikkelsen, Soren UNSPECIFIED orcid.org/0000-0002-5187-7027 UNSPECIFIED Zwisler, Stine Thorhauge UNSPECIFIED UNSPECIFIED UNSPECIFIED Andersen, Mikkel UNSPECIFIED UNSPECIFIED UNSPECIFIED Fenger-Eriksen, Christian UNSPECIFIED orcid.org/0000-0003-0536-560X UNSPECIFIED Isbye, Dan L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Rasmussen, Lars S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Steinmetz, Jacob UNSPECIFIED orcid.org/0000-0001-9620-8911 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-686908
DOI:	10.1136/bmjopen-2022-064047
Journal or Publication Title:	BMJ Open
Volume:	12
Number:	11
Date:	2022
Publisher:	BMJ PUBLISHING GROUP
Place of Publication:	LONDON
ISSN:	2044-6055
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ARTERIAL HYPEROXIA; ABDOMINAL-SURGERY; BRAIN-INJURY; FRACTION; MORTALITY; PNEUMONIA; OUTCOMES; ADULTS; RISK Multiple languages Medicine, General & Internal Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/68690